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Regulatory Manager

Exciting position within regulatory affairs and people management

 

As the new Regulatory Manager at Thermo Fisher, you will be responsible for the overall product safety and regulatory compliance of the manufacturing site located in Roskilde, and you will work closely with other global sites to ensure product compliance.

You will also be responsible for defining and executing regulatory strategy, providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities. You will have two specialists in direct report.

Key responsibilities include:

  • Responsible for regulatory surveillance. Provide support and inform R&D, Sourcing, Marketing and Commercial organizations about new regulatory compliance trends and developments. Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
  • Provide regulatory guidance (e.g. MDR, IVDR, FDA) to the business and project teams. Subject Matter Expert on various regulations and coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
  • Conduct trainings and/or communicate appropriate materials, like regulatory affairs internal policies and procedures, as needed, in order to enhance the team’s knowledge of working in a regulated environment
  • Compile, review and maintain regulatory submissions, technical documentation and labelling for completeness and quality. Prepare and submit tech files and other submissions as needed to regulatory agencies and notified bodies
  • Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations
  • Perform regulatory assessment of new and changed products. Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies
  • Review and approve product labelling, packaging advertising, promotional material and other marketing material for compliance with applicable regulations and standards
  • Maintain regulated product listing and product classification status as required by governing law and regulatory requirement
  • Work with Product Managers to review, evaluate and amend (as appropriate) current product portfolios to assess adequacy of medical device regulatory classification
  • Support post-market surveillance and vigilance activities, including submitting reports to authorities
  • Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits
  • Participate in customer audits/technical meetings when applicable
  • Participate in business meetings with internal stakeholders and existing and prospective external partners. Support Sourcing, Marketing and Commercial Organizations with regulatory requirements interpretation
  • Responsible for signing EC Declaration of Conformities
  • Supervising and leading team members

Your qualifications are a minimum of 4 years Biotechnology/Life Sciences industry experience, with a minimum of 2 years working experience in Regulatory/Quality or an applicable technical field. Experience with biocompatibility testing and extractable and leachable testing is highly desirable. Moreover, you have experience as RA representative on project core teams providing active and successful regulatory guidance and RA strategy. You have experience communicating with Regulatory Authorities and distributors together with experience with regulatory audits, ISO certification, GMP requirements, risk management and document control. Moreover, you have experience managing and leading a team.

You have a strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files. Finally, you must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.

You have a Bachelor Degree in Biology, Chemistry, Life Science, Bioengineering or equivalent.

You are a person with a high energy level, a positive attitude and you work well under pressure, together with being a strong communicator and leader. You are hands-on, action-oriented, and able to implement effectively through your team. You are continuously improvement minded, familiar with balancing the need for Quality and the need for efficiency and you are able to work autonomously in a matrix-managed organization. You have good people management and stakeholder management skills and you are comfortable with ambiguity and change.

Thermo Fisher offers an exciting position in which you will have a high degree of influence on your own job. The position will allow the you to create a sustainable footprint while developing professionally.

Travelling: 10-20% per year.

Domicile: The Thermo Fisher domicile in Roskilde.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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